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Brief Title: Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers
Official Title: The Effect of a Pre- and Post- Operative Exercise Programme Versus Standard Care on Physical Fitness in People With Upper Gastrointestinal Cancers- Study Protocol for a Randomised Control Trial: The PERIOP-OG Trial.
Study ID: NCT03807518
Brief Summary: Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.
Detailed Description: The comparator in this study will be standard oncological care. There patients will receive the exact same care as the intervention group patients but will receive no exercise training program. The primary goal of this multi-centre randomised controlled trial are to investigate the effects of peri-operative exercise training programmes on physical fitness, measured with a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer. The secondary aims will look at the effect of peri-operative exercise training on patients quality of life, optimism and well being, post operative morbidity, nutritional status and blood markers of inflammation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beaumont Hospital, Dublin, , Ireland
Name: William Robb, MB,BCh,BAO,BA,FRCSI,MD
Affiliation: Beaumont Hospital Dublin
Role: PRINCIPAL_INVESTIGATOR
Name: Noel McCaffrey, MB,BCh,BAO,BSc,MSc
Affiliation: Dublin City University
Role: STUDY_CHAIR
Name: Thomas Murphy, MB,BCh,BAO,FRCSI
Affiliation: Mercy University Hospital, Cork
Role: STUDY_CHAIR
Name: Jarlath Bolger, MB,BCh,BAO,MD
Affiliation: Beaumont Hospital
Role: STUDY_CHAIR
Name: Pamela Gallagher, Professor of Psychology
Affiliation: Dublin City University
Role: STUDY_CHAIR
Name: Claire Timon, BSc,PhD
Affiliation: University College Dublin
Role: STUDY_CHAIR
Name: Jan Sorensen, MSc, MA
Affiliation: Royal College of Surgeons, Ireland
Role: STUDY_CHAIR